MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 297354

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy broth the tube was contaminated and appeared "cloudy".The following information was provided by the initial reporter, translated from german to english: on (b)(6) 2023 during pre use inspection 1 vial with clouding was identified and sorted out.Before use.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6) h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: the batch history record (bhr) review for batch 2082265 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for turbid media.Retention samples from batch 2082265 ((b)(4) tubes) were available for inspection.No contamination was observed.To further evaluate, two tubes from retention samples were incubated.One tube was incubated for 7 days in 20-25c and one tube was incubated at 33-27c for 7 days; following 7 days the two tubes did not have any contamination.Two photos were received to assist with the investigation: the first photo shows two tubes side by side, the tube on the left has turbid media with bubbling on the top and the tube on the right has media that is visibly clear.The product label and cap of the tube are not present in this photo.The second photo also shows two tubes.The tube labels display material 297354, lot 2082265, and expiration 2023-09-20.The tube on the left contains a clear medium and the tube on the right contains a turbid media.The turbidity in the photos is likely caused by contamination.No returns were received to assist with the investigation.This complaint can be confirmed for contamination based on the evidence provided in the photos received.No complaint trends were identified for contamination; no actions are indicated at this time.Bd will continue to trend complaints for defects.

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy broth the tube was contaminated and appeared "cloudy".The following information was provided by the initial reporter, translated from german to english: on (b)(6) 2023 during pre use inspection 1 vial with clouding was identified and sorted out.Before use.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17580726
• MDR Text Key: 321754694
• Report Number: 1119779-2023-00911
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 00382902973546
• UDI-Public: 00382902973546
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/20/2023
• Device Catalogue Number: 297354
• Device Lot Number: 2082265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1